Class IIOngoing

Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only, M… recall

FDA recall D-0029-2026 · initiated Oct 7, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg).

Details

Product: Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ, 08816, Manufactured by Suven Pharmaceuticals Limited, Pashamylaram, Telangana, 205307, India. NDC# 16571-691-01
Recalling company: Rising Pharma Holding, Inc.
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Distributed Nationwide in the USA
Initiated: Oct 7, 2025
FDA report date: Oct 22, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0029-2026 ↗

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